Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to Methotrexate

A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221588

Enrollment

406

Registered

2011-09-20

Start date

2011-09-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

investigational material(s) Generic name etc : Clazakizumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inadequate response to Methotrexate. Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of 7.5 mg and stable dose for 4 weeks prior to randomization. ACR global function status class 1-3. Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist. High sensitivity C-reactive protein (hsCRP) more than 0.8 mg/dL

Exclusion criteria

Exclusion criteria: Previously received or currently receiving concomitant biologic therapy.

Design outcomes

Primary

Measure	Time frame
Compare the efficacy of Clazakizumab subcutaneous (SC) vs placebo on a background of Methotrexate (MTX) as assessed by 20% American College of Rheumatology criteria (ACR) response.	—

Secondary

Measure	Time frame
To assess additional efficacy outcomes of Clazakizumab SC at 12 weeks as measured by ACR50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes. To assess efficacy of Clazakizumab SC at 24 weeks as measured by ACR 20, 50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes. To assess radiographic progression of joint damage by MRI at 12 Weeks. To assess radiographic progression of joint damage by x-ray at 24 Weeks. To assess safety and tolerability including immunogenicity rates.	—

Measure

Time frame

To assess additional efficacy outcomes of Clazakizumab SC at 12 weeks as measured by ACR50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes. To assess efficacy of Clazakizumab SC at 24 weeks as measured by ACR 20, 50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes. To assess radiographic progression of joint damage by MRI at 12 Weeks. To assess radiographic progression of joint damage by x-ray at 24 Weeks. To assess safety and tolerability including immunogenicity rates.

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026